drugset / Trial / NCT04464707

A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 6 to 17 Years of Age

NCT04464707

Phase 3 Completed 292 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab The total duration of the study is planned to be 75 months.

Timeline

Start
2020-09-24
Primary completion
2024-11-29
Completion
2024-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Fremanezumab Monoclonal antibody Subcutaneous

Indications